Kairav Chemicals Ltd
⚠️ Moderate Risk
FEI: 3003743917 • Ahmedabad, Gujarat • INDIA
FEI Number
3003743917
Location
Ahmedabad, Gujarat
Country
INDIAAddress
901 Parshwa Tower, , Ahmedabad, Gujarat, India
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
How is this score calculated?
Proprietary Algorithm
- 40% Violation Severity — AI-assessed (1-10)
- 30% Refusal Volume — Logarithmic scale
- 20% Recency — Decays over 5 years
- 10% Frequency — Refusals per year
© ImportRefusal.com Original Analysis
Violation Summary
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
NEW VET DR
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be a new animal drug that is unsafe within the meaning of Section 512(a) of the Federal Food, Drug, and Cosmetic Act as it is not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing, and no investigational new animal drug exemption applies.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/23/2011 | 62GCS18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 2/13/2009 | 62GAS18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 9/22/2008 | 62GAS18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 12/15/2006 | 62GCS18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 8/30/2002 | 68YAK20ANIMAL DRUGS N.E.C. USED MORE THAN 1 SPECIES | Detroit District Office (DET-DO) |
Frequently Asked Questions
What is Kairav Chemicals Ltd's FDA import refusal history?
Kairav Chemicals Ltd (FEI: 3003743917) has 5 FDA import refusal record(s) in our database, spanning from 8/30/2002 to 11/23/2011.
What is an FEI number?
FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. Kairav Chemicals Ltd's FEI number is 3003743917.
What types of violations has Kairav Chemicals Ltd received?
Kairav Chemicals Ltd has been cited for 6 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.
Where does this information about Kairav Chemicals Ltd come from?
All FDA import refusal data for Kairav Chemicals Ltd is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.
Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.